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Comparison of 2 Techniques Using EUS Guided Liver Biopsies Via 19g CORE Biopsy Needle to Obtain Optimal Core Liver Biopsies in Benign Disease
The primary purpose of this prospective, randomized, multicenter study is to evaluate and compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2 different techniques of EUS guided CORE liver biopsy for benign disease. The two techniques: "modified Wet suction" and "Slow pull" technique of collecting tissue from a liver biopsy via Endoscopic Ultrasound (EUS).
Each subject will have a biopsy performed via one of 2 different techniques: "modified wet suction", or "slow pull" technique. A randomization process will determine which technique. Each subject shall undergo 2 passes (2 cores of tissue will be obtained - ideally from the right and left lobe of the liver. Quality of tissue obtained via the 2 different techniques will be evaluated by number of fragments, length of specimens and number of tracts observed by the local pathologist and compared between the tissues obtained from the two techniques. .
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University South Alabama
Mobile, Alabama, United States
Santa CLara Valley Medical Center
San Jose, California, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
Oschner Health System
New Orleans, Louisiana, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Baylor Medical Center
Houston, Texas, United States
Start Date
March 8, 2018
Primary Completion Date
September 15, 2020
Completion Date
September 15, 2020
Last Updated
April 7, 2022
153
ACTUAL participants
Core Liver Biopsy
DIAGNOSTIC_TEST
Lead Sponsor
Parkview Health
NCT05264051
NCT06493773
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07150624